1 Colo. Code Regs. § 212-3-3-905

Current through Register Vol. 47, No. 7, April 10, 2024

Section 1 CCR 212-3-3-905 - Business Records Required

Basis and Purpose - 3-905

The statutory authority for this rule includes but is not limited to sections 44-10-202(1)(c), 44-10-203(1)(c), 44-10-203(1)(k), 44-10-301, and 44-10-1001(1) and (3), C.R.S. This rule explains what business records a Licensee must maintain and clarifies that such records must be made available to the Division on demand. This Rule 3-905 was previously Rules M and R 901, 1 CCR 212-1 and 1 CCR 212-2.

A.General Requirements.

1. A Regulated Marijuana Business must maintain the information required in this Rule in a format that is readily understood by a reasonably prudent business person and may be stored electronically.

2.Location of Required Records.

a.On premises records: The Regulated Marijuana Business's books and records for the preceding six months (or complete copies of such records) must be maintained on the Licensed Premises at all times. Electronic records that are accessible from, but not physically located at, a Licensee's Licensed Premises may also satisfy the requirements of this Rule 3-905.

b.On- or off-premises records: Books and records associated with older periods may be archived on or off of the Licensed Premises.

3. Books and records necessary to fully account for the business transactions conducted under its License shall be made available to the State Licensing Authority or Division upon request.

B. The books and records that are required to be maintained for the current calendar year and the preceding calendar year are:

1. Secure Facility Information - For its Licensed Premises and any associated permitted off-premises storage facility, a Regulated Marijuana Business must maintain the business contact information for vendors that maintain video surveillance systems and Security Alarm Systems.

2. Security Alarm Systems documents required by Rule 3-220(A)(3).

3. Advertising Records - All records related to Advertising and marketing, including, but not limited to, audience composition data.

4. Child Resistance Certificates - A copy of the certificate that each Container into which a Licensee places Regulated Marijuana is Child Resistant.

5. Diagram for the Licensed Premises - Diagram of all approved Limited Access Areas, Restricted Access Areas, and any permitted off-premises storage facilities.

6. Visitor Log - List of all visitors entering Limited Access Areas or Restricted Access Areas.

7. Repealed.

8. Waste Log and Fibrous Waste Records - Comprehensive records regarding all waste and Fibrous Waste material that accounts for, reconciles, and evidences all waste and Fibrous Waste activity related to the disposal of marijuana.

9. Consumer Waste Records - All contracts, standard operating procedures, and receipts relating to collection and Transfer of Marijuana Consumer Waste as required by Rule 3-240.

10. Surveillance Logs - Surveillance logs identify all authorized employees and service personnel who have access to the surveillance system and maintenance and activity log as required by Rule 3-225.

11. Every Licensee shall maintain a record of its identity statement and Standardized Graphic Symbol. A Licensee may elect to have its Identity Statement also serve as its Standardized Graphic Symbol for purposes of complying with this rule.

12. Testing Records Required to be Maintained by Regulated Marijuana Testing Facilities:

a. All testing records required by Rule 5-450 and Rule 6-450.

b. Digital photographs of each Test Batch.

c. Any delegation of responsibilities from the laboratory director to a qualified supervisory analyst as permitted by Rule 5-240(B)9 or 6-240(B).

13. Testing Records Required to be Maintained by Regulated Marijuana Businesses and Accelerator Licensees:

a. Documentation of Designated Test Batch Collector Training required by Rule 4-110(C)(3).

b. Records regarding wet whole plant that was not tested for microbials pursuant to Rule 4-121(F)(3).

c. Evidence of any achieved Reduced Testing Allowance - If a Licensee utilizes any Reduced Testing Allowances, then they must maintain documentation demonstrating how it was obtained and maintained throughout the allowance with all applicable rules.

14. Sampling Unit Records - All records related to designated Sampling Managers, identified Sampling Units, and Transfers of Sampling Units. See Rules 3-810, 5-230, 5-320, 6-225, 6-320. This includes, but is not limited to, standard operating procedures that explain the requirements of sections 44-10-502(5), 44-10-503(10), 44-10-602(6) and 44-10-603(10), C.R.S., the personal possession limits pursuant to section 18-18-406, C.R.S., and the requirements imposed by Rules 5-230, 5-320, 6-225, 6-320. 6-725, and 6-280.

15. License Application Records - All records provided by the Licensee to both the state and local licensing authorities in connection with an application for licensure pursuant to the Marijuana Code and these Rules.

16. Repealed.

17. Audited Product and/or Alternative Use Product Records - All records required to demonstrate compliance with Rule 5-325 and 6-325.

18. Repealed.

19. Certificates of analysis or other records demonstrating the full composition of each Ingredient used in the manufacture of Vaporizer Delivery Devices or Pressurized Metered Dose Inhalers as required by Rule 5-310(F).

20. Records required to be maintained by Delivery Permit holders including delivery order requirements and contracts for delivery pursuant to Rule 3-615.

21. Recall records required by Rule 3-336 including the recall plan, recall notice, and results of any action taken pursuant to the recall plan.

22. All records related to Material Changes as required by Rules 3-330(D) and 3-335(L).

23. Records related to Adverse Health Events as required by Rule 3-920.

24. Internal Security Controls - Licensees must establish and maintain a security plan for each Licensed Premises, including at a minimum:

a. Protocols for the end-of-day handling of Regulated Marijuana and cash;

b. Protocols for reporting theft or burglaries when they are discovered to Local Law Enforcement, the Division, and Local Licensing Authority or Local Jurisdiction;

c. Protocols for reconciling inventory after a theft or burglary has been discovered;

d. Identification of exterior lighting of the Licensed Premises and any exterior camera angles, and protocols for maintenance of the lighting and cameras; and

e. Identification of ingress and egress routes for the property and identification of any access control measures taken outside of the Licensed Premises.

25. Patient Documents - Documents required for a patient to register a primary Medical Marijuana Store as required by Rule 5-110(D).

26. Regulated Marijuana Concentrate Production Records - All records required by Rules 5-315, 6-315, and 6-815 regarding production of Regulated Marijuana Concentrate.

27. Marijuana Research and Development Facility Records - Documents and correspondence sent to or received from an independent reviewer or the Scientific Advisory Council and any testing records if required by Rule 5-725.

28. Documents Related to Pesticide Manufacturers - Affidavit from a Pesticide Manufacturer that it meets the requirements of the Rule and the written agreement between the Licensee and the Pesticide Manufacturer as required by Rule 7-115.

29. Expiration date and use-by date documents required by Rule 3-335(M), 3-1005, and 3-1015.

30. Written report of change of management personnel as required by Rule 3-920(A)(2).

31. Current Owner and Employee List - This list must provide the full name and License number of all Owner Licensees and every employee who works for a Regulated Marijuana Business. The list shall include all employees who work for the Regulated Marijuana Business, whether or not they report to the Licensed Premises as part of their employment. A Regulated Marijuana Business can fulfill the requirements of this Rule by listing all employees in the Inventory Tracking System for each Licensed Premises. If a Regulated Marijuana Business does not use the Inventory Tracking System to list all employees, it must maintain a separate record for employees who do not report to the Licensed Premises.

32. Repealed.

33. Source Genetic Material Records - Licensees receiving Genetic Material in accordance with Rules 5-305 and 6-305 must maintain the following records:

a. The name, address, and license/registration/permit identification of the source of the Genetic Material;

b. All certificates of analysis associated with the Genetic Material, if available; and

c. Any other records that clearly document the chain of custody of the Genetic Material, such as an invoice, packing slip, or other document showing the origin of the Genetic Material.

34. Procedures for compliance with online sales.

35. All other records required by these Rules.

B. 5 Each Regulated Marijuana Business shall retain the following records for the current year and three immediate prior tax years:

1. Tax documents in accordance with section 44-10-1001(3), C.R.S.;

2. All books and records necessary to fully account for the business transactions conducted under its license;

3. Standard Operating Procedures and Training Documentation - All standard operating procedures, including revision date, as required by these Rules must be maintained for the current year and three previous calendar years. In addition to maintaining standard operating procedures, Regulated Marijuana Businesses must maintain up-to-date records of employee training as follows:

a. Identification of required training of employees;

b. Documentation of training topic, training method, date of initial training, date of any necessary re-training, name and signature of trainer, and name and signature of employee;

c. Competency and effectiveness of employee training shall be adequately assessed in an appropriate manner determined by the Licensee that is described in the standard operating procedures.

4. Corrective Action and Preventive Action records required by Rules 5-115, 5-210, 5-310, 6-110, 6-210, 6-310, 6-710, 6-810, and 6-1110.

5. Documentation required to demonstrate valid responsible vendor designation(s).

6. Cleaning records and Maintenance records required under Rule 3-330(D)(1)(e).

C.Records Required to be Maintained in the Inventory Tracking System. The following records must be maintained by Licensees in the Inventory Tracking System:

1. Records Related to Inventory Tracking. A Regulated Marijuana Business must maintain accurate and comprehensive inventory tracking records that account for, reconcile, and evidence all inventory activity for Regulated Marijuana from either seed or Immature Plant stage until the Regulated Marijuana is destroyed or Transferred to another Regulated Marijuana Business, a consumer, a patient, or a Pesticide Manufacturer.

2. Records Related to Transport. A Regulated Marijuana Business must maintain adequate records for the transport of all Regulated Marijuana. See Rule 3-605 - Transport: All Regulated Marijuana Businesses.

3. Employees Required to be Listed in the Inventory Tracking System. A Regulated Marijuana Business must use the Inventory Tracking System to list all employees who report to the Licensed Premises. The employee list in the Inventory Tracking System must include the full name and Employee License number of every employee who works on the premises. The Regulated Marijuana Business is responsible for updating its list of employees who work at the Licensed Premises in the Inventory Tracking System within 10 days of an employee commencing or ceasing employment.

4. Testing results.

D.Loss of Records and Data. Any loss of electronically-maintained records shall not be considered a mitigating factor for violations of this Rule. Licensees are required to exercise due diligence in preserving and maintaining all required records.

E.Violation Affecting Public Safety. Violation of this Rule may constitute a license violation affecting public safety.

F.Provision of Any Requested Record to the Division. A Licensee must provide on-demand access to on-premises records following a request from the Division during normal business hours or hours of apparent operation, and must provide access to off-premises records within three business days following a request from the Division.

1 CCR 212-3-3-905

42 CR 23, December 10, 2019, effective 1/1/2020

43 CR 21, November 10, 2020, effective 1/1/2021

44 CR 07, April 10, 2021, effective 5/1/2021

44 CR 13, July 10, 2021, effective 8/1/2021

44 CR 23, December 10, 2021, effective 1/1/2022

45 CR 21, November 10, 2022, effective 12/1/2022

46 CR 23, December 10, 2023, effective 1/8/2024